Adjustable sleep apnea oral appliance

ABSTRACT

An oral appliance having an upper tray, a lower tray, and axial inserts attached to either the upper tray or lower tray to adjust the relative position of a user&#39;s upper jaw and lower jaw in order to treat sleep apnea and/or snoring while at the same time allowing orthodontic treatment of the subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the U.S. national stage of International PatentApplication No. PCT/US2015/066209, filed on Dec. 16, 2015 and entitledADJUSTABLE SLEEP APNEA ORAL APPLIANCE, which claims the benefit ofpriority under 35 U.S.C. § 120 from U.S. Patent Application No.62/092,761, filed on Dec. 16, 2014 and titled ADJUSTABLE SLEEP APNEAORAL APPLIANCE. The disclosure of the foregoing application isincorporated herein by reference in its entirety.

BACKGROUND

Sleep apnea is a disorder characterized by abnormal pauses in breathingor instances of abnormally low breathing during sleep. Each pause inbreathing, called an apnea, can last from a few seconds to minutes(typically lasting 20 to 40 seconds) and may occur 5 to 30 times or morean hour. Sleep apnea results from a partial-to-complete blockage of asubject's airway. Increased air speed through the airway causes anincrease in dynamic pressure and a corresponding drop in staticpressure. The decreased static pressure can in some instances draw backthe lower jaw and tongue and thereby block the airway. This blockage canincrease to the point of becoming complete, which at least temporarilyinterrupts breathing.

Subjects are generally at greater risk for sleep apnea if they areoverweight or have conditions such as diabetes, hypertension, or chronicnasal congestion. There are a variety of factors, however, which canlead to sleep apnea. One factor is the presence of a narrow maxillaand/or mandible in a subject. Maxillary constriction may increase nasalresistance and alter the tongue posture, leading to narrowing of theretroglossal airway. Constriction of the maxilla and/or the mandiblegenerally reduces intraoral air volume and tends to force the tongueback into the posterior airway space, leading to obstructive sleep apneaduring sleep.

Orthodontics is a field of dentistry which focuses on the repositioningof a subject's teeth and jaws for aesthetic or other reasons, forexample due to the “overcrowding” of a subject's teeth. Orthodonticmethods typically require a subject to make continuous use of a dentalappliance for a period of time in order to achieve results. The use ofsuch appliances precludes the concurrent use of currently available oralappliances for treating sleep apnea. There remains a need therefore forimproved devices and methods for treating sleep apnea in users oforthodontic appliances who experience sleep apnea.

SUMMARY

The present oral appliance comprises an upper tray and a lower traywhich are respectively configured both to treat snoring and/or sleepapnea in a subject and to effect orthodontic treatment of the subject.In one embodiment, the upper tray comprises:

-   -   (a) a receptacle bounded by the inner surface of the upper tray;    -   (b) a right side upper bite pad connected at an upper end to the        lower surface of the right side of the upper tray, wherein the        bite pad comprises a lower surface, an anterior surface, a        posterior surface, a right side, and a left side, the bite pad        extending anteriorly from a posterior portion of the right side        of the upper tray, wherein the lower surface of the bite pad is        lower than the lower, coronal surface of an anterior portion of        the right side upper tray;    -   (c) a right side insert comprising an upper surface, a lower        surface, an anterior surface, a posterior surface, a right side,        and a left side, wherein the upper surface faces and/or contacts        the lower surface of the right side of the upper tray anteriorly        with respect to the right side upper bite pad, and wherein the        posterior surface is configured to be reversibly attached to the        anterior surface of the right side upper bite pad;    -   (d) a left side upper bite pad connected at an upper end to the        lower surface of the left side of the upper tray, wherein the        bite pad comprises a lower surface, an anterior surface, a        posterior surface, a right side, and a left side, the bite pad        extending anteriorly from a posterior portion of the left side        of the upper tray, wherein the lower surface of the bite pad is        lower than the lower, coronal surface of an anterior portion of        the left side upper tray;    -   (e) a left side insert comprising an upper surface, a lower        surface, an anterior surface, a posterior surface, a right side,        and a left side, wherein the upper surface faces and/or contacts        the lower surface of the left side of the upper tray anteriorly        with respect to the left side upper bite pad, and wherein the        posterior surface is configured to be reversibly attached to the        anterior surface of the left side upper bite pad; and    -   (f) a buccally facing anterior right side anchor on the outer        buccal surface of the anterior portion of the right side of the        upper tray, and a buccally facing anterior left side anchor on        the outer buccal surface of the anterior portion of the left        side of the upper tray.

In this embodiment, the lower tray comprises:

-   -   (a) a receptacle bounded by the inner surface of the upper tray;    -   (b) a right side lower bite pad connected at a lower end to the        upper surface of the right side of the lower tray, wherein the        bite pad comprises an upper surface, an anterior surface, a        posterior surface, a right side, and a left side, the bite pad        extending posteriorly from an anterior portion of the right side        of the lower tray, wherein the upper surface of the bite pad is        higher than the upper, coronal surface of a posterior portion of        the right side lower tray;    -   (c) a left side lower bite pad connected at a lower end to the        upper surface of the left side of the upper tray, wherein the        bite pad comprises an upper surface, an anterior surface, a        posterior surface, a right side, and a left side, the bite pad        extending posteriorly from an anterior portion of the left side        of the lower tray, wherein the upper surface of the bite pad is        higher than the upper, coronal surface of a posterior portion of        the left side lower tray;    -   (d) a buccally facing anterior right side anchor on the outer        buccal surface of the anterior portion of the right side of the        lower tray, and a buccally facing anterior left side anchor on        the outer buccal surface of the anterior portion of the left        side of the lower tray; and    -   (e) a buccally facing posterior right side anchor on the outer        buccal surface of the posterior portion of the right side of the        lower tray, and a buccally facing posterior left side anchor on        the outer buccal surface of the posterior portion of the left        side of the lower tray,

With the foregoing arrangement, the anterior surface of the right sideinsert forms an engagement surface which contacts the posterior surfaceof the right side lower bite pad, and the anterior surface of the leftside insert forms an engagement surface which contacts the posteriorsurface of the left side lower bite pad. This limits the forwardpositioning of the upper tray with respect to the lower tray, therebyalleviating snoring and/or apnea when the oral appliance is used by asubject.

Another unique feature of the present appliance is that it allowsorthodontic treatment of a subject while simultaneously treating snoringand/or apnea. In one embodiment, the receptacles of the upper tray andthe lower tray are each configured to receive and retain orthodontictrays, preferably a series of orthodontic trays. In another embodiment,the receptacles of the upper tray and the lower tray are each configuredto reposition one or more teeth of a subject and/or to change theconfiguration of a subject's mandible and/or maxilla when the applianceis worn by the subject.

In an alternative embodiment, the positions of the upper and lower bitpads can be reversed, so that the lower bite pad is positioned in aposterior portion of the lower tray, and the insert can be attached tothe anterior end of the lower bite pad. In this case, the upper bite padis positioned anteriorly, and the anterior surface of the insert engagesthe posterior surface of the upper bite pad.

FIGURES

FIG. 1 is a left side, top perspective view of an embodiment of thepresent oral appliance, including elastic bands.

FIG. 2 is a top plan view of the upper portion of the appliance of FIG.1.

FIG. 3 is a left side, bottom perspective view of the upper portion ofthe appliance of FIG. 1.

FIG. 4 is a left side, bottom perspective view of the upper portion ofthe appliance in another embodiment.

FIG. 5 is a top plan view of the lower portion of the appliance of FIG.1.

FIG. 6 is right side, top perspective view of the lower portion of theappliance of FIG. 1.

FIG. 7 is a left side, top perspective view of an embodiment of the oralappliance of FIG. 1.

FIG. 8 is a left side, top perspective view of another embodiment of thepresent oral appliance.

FIG. 9 is a left side, top perspective view of the embodiment of FIG. 8,including elastic bands.

FIG. 10 is a front, top and front, bottom perspective view of an insertused with the present oral appliance.

FIG. 11 is a front, top perspective view of three inserts used with thepresent oral appliance.

FIG. 12 is a top plan view of the inserts of FIG. 11.

FIG. 13 is a left side, bottom perspective view of the upper portion ofthe appliance of FIG. 1, showing the placement of an insert.

FIG. 14 is an exploded, top left side perspective view of an alternativeembodiment of the present appliance for use with dental trays.

FIG. 15 is a left side, top perspective view of another embodiment ofthe oral appliance.

DESCRIPTION

Definitions

As used herein, the following terms and variations thereof have themeanings given below, unless a different meaning is clearly intended bythe context in which such term is used.

“Anchor” refers to a component of the present appliance which is securedto a portion of the appliance and assists in connecting that portion toanother portion of the appliance.

“Anterior” means in the direction of or toward or adjacent the frontportion (opening) of a subject's mouth.

“Apnea” and “sleep apnea” refer to a temporary cessation of breathingand/or to instances of shallow or infrequent breathing during sleep,generally caused by a blockage of a subject's airway (referred to asobstructive sleep apnea).

“Buccal” means in the direction of or toward a subject's cheek. Inrelation to a subject's teeth, this refers to the side of the teethfacing the cheek.

“Coronal plane” refers to a hypothetical planar surface that extendsthrough the body from the head to the feet, and divides the body intofront and rear halves.

“Coronal” refers to a position or direction which is on or toward thedistal end of a tooth (i.e., where the biting surface is located). Acoronal surface is thus the biting surface of a tooth, which inposterior teeth is generally referred to as an occlusal surface and onanterior teeth is called an incisal surface. “Coronal surface” may alsorefer to the corresponding surface of a dental tray which contacts theother dental tray when the present device is worn by a user, i.e. to alower surface of an upper dental tray or to an upper surface of a lowerdental tray.

“Dental tray” refers to a structure comprising a receptacle forreceiving the teeth of a subject. In some embodiments, the receptaclehas an opening for receiving teeth and an interior surface whichcontacts the subject's teeth directly. In other embodiments, thereceptacle receives an orthodontic tray.

“Downward” and “downwardly” mean in the direction of or toward a lowerportion of a subject's body. “Upward” and “upwardly” mean in theopposite direction, i.e. in the direction of or toward an upper portionof a subject's body.

“Elongated” refers to a configuration or shape having a length which islonger than its width.

“Forward” means in a direction toward the anterior (front portion) of asubject's mouth.

“Horizontal,” with respect to the present appliance, refers todisposition in a plane approximately perpendicular to the sagittaland/or the coronal plane of a subject, i.e. within 15 degrees of such aperpendicular plane.

“Labial” means in the direction of, toward, or adjacent to a subject'slips. In relation to a subject's teeth, this refers to the side of thefront teeth facing the lips.

“Lateral” means away from the sagittal plane of a subject.

“Left” means to the left of the center sagittal plane of a subject, fromthe perspective of the subject.

“Lingual” means in the direction of, toward, or adjacent to a subject'stongue. In relation to a subject's teeth, this refers to the side of theteeth facing the tongue.

“Lower” refers to the relative position of a component in the presentappliance which is closer to or toward a lower portion of a subject'sbody when being used. For example, and upper tray in the presentappliance is positioned above (higher than) a lower tray when theappliance is worn by a user, i.e. such that the upper tray is fittedover the maxillary dentition and the lower tray is fitted over themandibular dentition.

“Mandibular” refers to the lower jaw.

“Mandibular dentition” refers to the teeth of the lower jaw.

“Maxillary” refers to the upper jaw.

“Maxillary dentition” refers to the teeth of the upper jaw.

“Mechanically connected” means physically connected, either through aconnection based on direct physical contact or via another mechanicalstructure.

“Medial” means toward the center sagittal plane of a subject.

“Orthodontic” refers to a feature or an appliance which repositions theteeth and/or jaw(s) of a subject.

“Orthodontic tray” refers to a dental tray for receiving the upper orlower dentition of a subject. An interior surface of an orthodontic traycontacts the subject's teeth directly with sockets or depressions sizedto receive a subject's teeth.

“Post” refers to a component which protrudes from a surface andfunctions as a point of attachment for another component, such as anelastic band.

“Posterior” and “rearward” means in the direction of or toward oradjacent the rear portion of a subject's mouth.

“Right” means to the right of the center sagittal plane of a subject,from the perspective of the subject.

“Sagittal plane” refers to an imaginary plane that travels verticallyfrom the top to the bottom of the body of a subject, dividing it intoleft and right portions.

“Subject” refers to a user of the present appliance, usually a humanuser.

“Thermoplastic” refers to a material, generally a polymer material,which may be softened by heat and hardened by cooling in a reversiblephysical process. The thermoplastic materials used in some components ofthe present appliance retain their shape at 100° F. and preferablybecome soft (deformable) at a temperature of 212° F. or below.

“Tray” and “dental tray,” as used herein, refer to a generally U-shapedportion of the present appliance comprising an open area for receivingthe maxillary or mandibular teeth of a subject, as the case may be.

“Upper” refers to the relative position of a component in the presentappliance which is closer to or toward an upper portion of a subject'sbody when being used.

“Vertical,” with respect to the present appliance, refers to dispositionin a plane approximately parallel to the sagittal and/or the coronalplane of a subject, i.e. within 15 degrees of such a parallel plane.Preferably, vertical refers to a direction toward or away from asubject's head or feet.

The term “comprise” and variations of the term, such as “comprising” and“comprises,” are not intended to exclude other additives, components,integers or steps. The terms “a,” “an,” and “the” and similar referentsused herein are to be construed to cover both the singular and theplural unless their usage in context indicates otherwise. With regard torelative terms, such as left and right, the term is to be interpretedfrom the perspective of a user of the present appliance when theappliance is being worn by the user, if no other orientation isindicated.

Oral Appliance

The present appliance 10 generally comprises a pair of dental trays 15,an upper tray 100 and a lower tray 200, which cooperate to position asubject's jaws so as to avoid sleep apnea. The upper tray 100 is fittedonto a subject's maxillary dentition, while the lower tray 200 is fittedto the subject's mandibular dentition. The tray portions 15 of thepresent device have an interior surface 21, an exterior surface 23, aright side 12, a left side 14, an anterior portion 16, and a posteriorportion 18, and each comprise a generally U-shaped tooth-receivingreceptacle 20 formed on one horizontal side of the tray 15 to fit over asubject's dentition.

In one embodiment, the receptacle 20 is configured to receive the teethof a subject and to contact the teeth on an interior surface 21 of thetray 15. The receptacle 20 comprises lateral contiguous walls extendingfrom a bottom surface facing the coronal surfaces of a subject's teethtoward the maxilla or mandible, respectively, i.e. buccal wall 22 andlabial wall 24, so as to cover some or all of the buccal and labialsides of some or all of a subject's teeth. The trays 15 can be formed toconform to a subject's pre-existing dentition, or in a preferredembodiment can be formed to accomplish a change in the existingdentition and/or in the shape of a subject's mandible and/or maxilla, asdescribed further below.

The exterior portions of the trays 15 comprise a coronal surface 30formed on the horizontal side of the tray opposite the receptacle 20,i.e. on the exterior surface 23 of the tray 15. Each tray 15 furthercomprises a pair of respective bite pads 35 located on each lateral sideof the tray 15, either a lower bite pad 40 or upper bite pad 50, whichmay be formed integrally with a respective tray 15 or may be bondedthereto. In the illustrated embodiments, the bite pads 35 separate theupper and lower jaws, to help treat apnea, and in addition provide anopening 5 between the upper incisal surface 101 and lower incisalsurface 201 of the upper tray 100 and the lower tray 200, respectively,to allow air flow through a subject's mouth. Maintaining a subject'smouth in a slightly open position by separating the upper and lower jawsin this way also helps to treat apnea. In other embodiments, however,the upper incisal surface 101 and lower incisal surface 201 can contacteach other.

In the illustrated embodiments, each lower bite pad 40 comprises aprojection that extends distally with respect to the coronal surface 30of the lower tray 200, i.e. upwardly when worn by subject wearing thepresent appliance 10. The lower bite pad 40 is located in an anteriorportion 16 of each side 12, 14 of the lower tray 200, anterior to alower occlusal surface 30 of the tray 200 in the illustratedembodiments, but in other embodiments (in which the upper bite pad 50 islocated anteriorly) the lower bite pad 40 could be located in arelatively posterior position. The lower bite pad 40 comprises agenerally horizontal coronal surface 42 for contacting a correspondingocclusal surface 30 in an anterior portion of the upper tray 100. Lowerbite pad 40 further comprises a rearward-facing engagement surface 44 inthe posterior portion of the bite pad 40 extending downwardly from thecoronal surface 42 to the occlusal surface 30 of the exterior surface 23of the lower tray 200.

The upper tray 100 likewise comprises a pair of upper bite pads 50, eachof which extends downwardly from the exterior surface 23 of the uppertray 100. The upper bite pad 50 comprises a generally horizontal coronalsurface 52 for contacting a corresponding occlusal surface 30 in aposterior portion of the lower tray 200, and a forward-facing connectingsurface or connecting end 54 in the anterior portion of the upper bitepad 50. Each upper bite pad 50 comprises a projection that extendsdistally from the coronal surface 30 of the upper tray 100, i.e.downwardly when worn by subject wearing the present appliance 10, andincludes a generally horizontal coronal surface 52 for contacting acorresponding occlusal surface in a posterior portion of the lower tray200. The present appliance 10 is preferably configured such that whenworn by a user, the coronal surface 52 of the upper bite pad 50 contactsthe exterior, coronal surface 30 of the posterior portion of the lowertray 200 such that the coronal surface 42 of the lower bite pad 40 issimultaneously in contact with the coronal surface 30 of an anteriorportion of the upper tray 100.

A unique feature of the present oral appliance 10 is the use of axialinserts 300. The inserts 300 are configured to attach to one of thetrays 15 and to engage a bite pad 35 on the other tray 15 of the presentappliance 10. In the illustrated embodiments, the inserts 300 areattached to the upper tray 100 and engage the lower bite pad 40 of thelower tray. The bite pads 35 and inserts 300 together cooperate to limitand define the relative anterior-posterior positions of the maxilla andmandible of a user of the present appliance 10. As shown best in FIGS.10-12, each insert 300 comprises an engagement surface 302, a rightlateral side 304, a left lateral side 306, and an attachment end 310opposite the engagement surface 302. The insert 300 further comprises acoronal surface (lower surface when attached to an upper tray 100) 330and a tray contact surface (upper surface) 332 opposite the coronalsurface 330. When the attachment end 310 of the insert 300 engages theconnecting end 54 of the upper tray, the tray contact surface of theinsert 300 abuts the occlusal surface 30 of the upper tray 100 and thecoronal surface 330 of the insert 300 faces outwardly (downwardly). Thecoronal surface 330 is preferably parallel to the coronal surface 52 ofthe upper bite pad 50, and more preferably is configured in the sameplane.

The attachment end 310 and the connecting end 54 are preferably providedwith mutually fitting locking elements in order to retain the insert 300on the upper tray 100. In the illustrated embodiments, the attachmentend 310 of the insert 300 engages with the connecting end 54 of theupper tray 100 in a tongue-and-groove fashion, such that a laterallyflaring wedge 312 fits within a recess 56 formed in the connecting end54. As will be apparent to one of skill in the art, the insert 300 couldalternatively be provided with a groove and the connecting end 54 couldbe configured with a forwardly projecting “tongue,” or a differentlyconfigured projection could be used, such as a rounded sphere adapted tofit in a corresponding rounded hole. Other configurations can also beused to mechanically attach the insert 300 to the upper tray 100. In onealternative, an insert 300 could be attached to the upper bite pad 100with an expansion screw, thereby allowing the length of the insert 300to be further adjusted, as desired. It will also be apparent to those ofskill in the art that the insert 300 could alternatively be attached tothe lower tray 200, such as to the lower bite pad 40. In the illustratedembodiments, the sides 311, 313, and 315 of the wedge 312 preferablyform an interference fit with the groove or recess 56 in order tosecurely retain the insert in the present appliance 10. In a preferredembodiment, the insert 300 and/or the upper bite pad 50 are formed froman elastomeric material, and the tongue of the attachment end 310 isformed with slightly larger dimensions than the recess 56, so that whenthe tongue is urged into the recess 56, it exerts an outward force thathelps to retain it within the recess 56.

Once attached to the upper tray 100, the forward-facing engagementsurface 302 of the insert 300 is positioned to contact therearward-facing engagement surface 44 of the lower bite pad 40 when thepresent appliance 10 is worn by a user. As shown for example in FIG. 1,the insert's engagement surface 302 contacts the lower bite pad'sengagement surface 44 so as to limit the rearward movement of the user'smandible with respect to the maxilla, and thereby assist in alleviatingsleep apnea.

The insert engagement surface (anterior surface) 302 and lower bite padengagement surface (posterior surface) 44 are preferably angled, opposedsurfaces that interact to serve as advancement engagement surfaces forthe mandible. Both the posterior face (engagement surface) 44 of thelower bite pad 40 and the anterior face (engagement surface) 302 of theinsert may be angled, as shown in the illustrated embodiments, to assistin advancing the mandible as the trays 15 vertically close, employing acamming action. The engagement surface 44 is preferably disposed at anon-vertical angle with an upward and forward slant. The engagementsurface 44 may employ an irregular, non-flat, arcuate, concave or convexsurface or surface features that nonetheless allow the described slidingengagement. A vertical interface between the insert engagement surface302 and lower bite pad engagement surface 44 is also possible.

In order to be able to adjust the relative position of a user's maxillaand mandible when the present appliance 10 is worn, inserts 300 ofdifferent lengths can be used. As shown in FIG. 8, the inserts 300 canbe formed with lateral sides 304, 306 of different lengths, such thatthe engagement surfaces 302 of different inserts extend further forwardor rearward, depending on the need of the user. In FIGS. 11 and 12, theinserts labeled 321, 322, and 323 comprise lateral sides 304, 306 ofincreasing length. As a result, a user's mandible can be positionedrelatively anteriorly through the use of longer inserts, i.e. withlonger lateral sides 304, 306, or can be positioned relativelyposteriorly through the use of inserts with shorter sides. A set ofinserts can be provided for use with the present appliance 10 havinglateral sides that differ in increments of 1 mm, increments of 0.5 mm,or increments of 0.25 mm, for example. For this reason, attachment ofthe inserts 300 to the upper tray 100 via a mechanical connection ispreferred, so that the attachment is reversible, and can be changed asneeded. However, other means of engagement, such as through chemicalmeans (e.g., glue) are also possible.

The upper and lower appliance trays 100, 200 are mechanically connectedvia anchors 60 in order to maintain the upper tray 100 in apredetermined position with respect to the lower tray 200. Inparticular, the anchor 162 of the left side portion of the upper tray100 is mechanically connected to the anchor 262 of the left side portionof the lower tray 200, and the anchor 162 of the right side portion ofthe upper tray 100 is mechanically connected to the anchor 262 of theright side portion of the lower tray 200. The anchors can be, forexample, a button 62, a hook 64, or a Herbst screw, and can bemechanically connected by appropriate connectors, such as orthodonticrubber bands, telescoping shims, and/or plastic connectors.

As shown in the illustrated embodiments, once the trays 100, 200 havebeen fitted for a particular subject, elastic bands 400 are placed onbuccal buttons 62 as shown in FIGS. 1 and 9. The buccal buttons 62 areposts or projections which extend buccally from the outer surfaces 23 ofthe upper tray 100 and lower tray 200, respectively. As seen in FIG. 5,they comprise a laterally extending portion 152 to which an elastic band400 can be secured and a circumferential “button” portion 154 extendingaway from the axis of the laterally extending portion 152 at the distalend of the buccal button 62, in order to better secure an elastic band400 on the buccal button 62.

In the illustrated embodiments, an anterior-posterior (diagonal) elasticband 420 extends from the anterior of the upper tray 100 to theposterior of the lower tray 200, between an upper anterior anchor 162and a lower, relatively posterior anchor 264. The force exerted by thiselastic urges the mandible forward in relation to the maxilla. A second,vertically extending elastic 440 extends between the upper anterioranchor 162 and a lower anterior anchor 262, generally between the firstbicuspid region on both trays 50 and generally in vertical alignment.The vertically extending elastic 440 provides a “closed-mouth” postureduring sleep. This combination of elastic bands gently holds themandible in the position determined by the present appliance 10 and alsoencourages nasal breathing by preventing the mandible from opening anddropping back.

The present appliances 10 can be formed from a variety of orallycompatible materials, typically polymers. In one embodiment, acrylic isused to form the present appliance. Thermoplastic polymers are typicallyused in the present appliance, but thermosets, thermoplastic elastomers,and other materials can also be used. The thermoplastic materials thatare used must be capable of retaining their shape when used by asubject, and thus preferably remain solid at least at about 100° F., andpreferably remain solid at somewhat higher temperatures, such as at 110°F., 120° F., or higher. When thermoplastic materials are used to formthe present trays, they preferably become deformable at a temperature of212° F. or less, so that they can be made plastic by being placed inboiling water. Preferably, the material is not deformable at less than120° F., preferably at not less than 145° F.

Orthodontic Trays

In one embodiment, the trays 15 can be formed as a series of orthodonticdental trays for use by a subject. In this embodiment, trays 15 havingdifferently-configured receptacle portions 20 are applied to the subjectover time in order to reposition individual teeth in successive stepsand/or to change the configuration of a subject's mandible and/ormaxilla. The successive use of a number of such dental trays 15 permitseach appliance to be configured to move individual teeth in smallincrements, typically less than 2 mm, preferably less than 1 mm, andmore preferably less than 0.5 mm (referring to the maximum lineartranslation of any point on a tooth as a result of using a singleappliance). The use of the inserts 300 of the present appliance 10provides a great advantage when orthodontic trays are used in thepresent invention, because an optimum relative position of the mandibleand maxilla of a user can be provided using an insert having a desiredlength, thereby addressing a user's sleep apnea while allowingorthodonture.

The tooth-receiving receptacle portions 20 of the dental trays 15typically have a geometry corresponding to an intermediate or end tootharrangement intended for a subject. When such a tray 15 is first worn bythe subject, certain of the teeth will be misaligned relative to anundeformed geometry of the receptacle portion 20 of a tray 15. In thisembodiment, the tray 15 is formed from a material that is sufficientlyresilient to accommodate or conform to the misaligned teeth, but willapply sufficient resilient force against such misaligned teeth toreposition the teeth to the intermediate or end arrangement desired forthat treatment step. The appliance will preferably, but not necessarily,fit over all teeth present in the upper or lower jaw. In some cases onlycertain teeth will be repositioned while will provide a base or anchorregion for holding the repositioning appliance in place as it appliesthe resilient repositioning force against the tooth or teeth to berepositioned

A subject's teeth are repositioned from an initial tooth arrangement toa final tooth arrangement by placing a series of incremental positionadjustment appliances in the subject's mouth. The first tray applianceof the series will have a geometry selected to reposition the teeth fromthe initial tooth arrangement to a first intermediate arrangement. Afterthe first intermediate arrangement is approached or achieved, one ormore additional (intermediate) appliances will be successively placed onthe teeth, where such additional appliances have geometries selected toprogressively reposition teeth from the first intermediate arrangementthrough successive intermediate arrangement(s). The treatment will befinished by placing a final appliance in the subject's mouth, where thefinal appliance has a geometry selected to progressively repositionteeth from the last intermediate arrangement to the final tootharrangement.

In order to design a series of dental trays 15 that will reposition aparticular subject's teeth, a digital data set representing an initialtooth arrangement and a final tooth arrangement can be determined. Theinitial data set representing the initial tooth arrangement, which canbe presented as a visual image, is manipulated to reposition individualteeth. A final digital data set is then produced which represents thefinal tooth arrangement with repositioned teeth. The initial digitaldata set may be provided by conventional techniques, includingdigitizing X-ray images, images produced by computer-aided tomography(CAT scans), images produced by magnetic resonance imaging (MRI), and/orby other methods known to the art for producing three-dimensionaldigital representations of a subject's teeth. Alternatively, the initialdigital data set may be provided by producing a plaster cast of thesubject's teeth (prior to treatment) by conventional techniques, forexample, and the plaster cast can then be scanned using laser or otherscanning equipment to produce a high resolution digital representationof the plaster cast of the subject's teeth.

Once the initial and final data sets have been determined, a series ofintermediate data sets, representing intermediate tooth positions for asubject's teeth, are determined. The successive intermediate digitaldata sets are preferably produced by determining positional differencesbetween selected individual teeth in the initial data set and in thefinal data set and interpolating the differences. Such interpolation maybe performed over at least three discrete stages, embodied in threedifferent dental trays, more often at least ten, sometimes at leasttwenty-five, and occasionally forty or more. The interpolation can be alinear interpolation for some or all of the positional difference, oralternatively may be nonlinear. The positional differences willcorrespond to tooth movements where the maximum linear movement of anypoint on a tooth is preferably 2 mm or less, usually 1 mm or less, andpreferably 0.5 mm or less.

Once the intermediate and final data sets have been determined, theappliances can be fabricated, such as with a rapid prototyping device ordigital printer. Preferably, the appliance is polymeric and is formedfrom a thin sheet of a suitable elastomeric polymeric, such as Tru-Tain0.03 in. thermal forming dental material (Tru-Tain Plastics, Rochester,Minn. 55902). One structure corresponding to each of the dental trayappliances is produced.

The foregoing dental tray appliances and their use in orthodontictreatment are described in U.S. Pat. No. 5,975,893 and in other patentsassigned to Align Technology, Inc., including U.S. Pat. Nos. 621,562,6,217,325, 6,398,548, 6,626,666, 6,629,840, 6,699,037, 7,134,874,7,474,307, 8,105,080, and 8,562,340.

In embodiments in which tooth or jaw repositioning is not needed ordesired, such as following a successful orthodontic treatment, the upperand lower dental trays 15 can be formed in ways known to the art. Forexample, when the present appliance is formed from a thermoplasticpolymer, the upper dental tray 100 and lower dental tray 200 can befirst evaluated for their fit with a subject's mouth, after which thetrays can be softened, preferably by placing the appliance innear-boiling water for between several seconds and one minute. Thesoftened appliance is then placed in the subject's mouth in alignmentwith the subject's upper and lower teeth, and the subject is instructedto bite into the softened material to make an impression of the teeth inthe softened material. The tray material is then allowed to cool in themouth for approximately one minute, after which the appliance ispreferably soaked in cold water for an additional minute. Creating acustomized dental impression in the trays of the present appliance inother ways and using other materials can be accomplished by one of skillin the art using known methods.

In another embodiment, shown in FIG. 14, the present trays 15 can bedesigned to be used in combination with a set of separately formedorthodontic trays 400, typically formed from a polymer material. Asshown in FIG. 14, each of such orthodontic trays 400 usually comprisesan upper orthodontic tray 402, a lower orthodontic tray 404, an innersurface 403 for contacting at least some of a subject's teeth, an outersurface 405, an anterior portion 416, a posterior portion 418, a rightside 412, and a left side 414. In this embodiment, the receptacle 20 ofthe present appliance 10 is sized to receive and reversibly retain anorthodontic tray 400, generally by contacting an outer surface 405 of anorthodontic tray 400. In this way, a subject can use the orthodontictrays 400 during the day and then continue using them at night incombination with the present appliance 10 in order to obtain relief fromsleep apnea.

Although the present invention has been described in considerable detailwith reference to certain preferred embodiments, other embodiments arepossible. The steps disclosed for the present methods, for example, arenot intended to be limiting nor are they intended to indicate that eachstep is necessarily essential to the method, but instead are exemplarysteps only. Therefore, the scope of the appended claims should not belimited to the description of preferred embodiments contained in thisdisclosure.

Recitation of value ranges herein is merely intended to serve as ashorthand method for referring individually to each separate valuefalling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All references cited herein areincorporated by reference in their entirety.

What is claimed is:
 1. An oral appliance for treating snoring and/orsleep apnea in a subject, comprising: (1) an upper tray having ananterior portion, a posterior portion, a right side, a left side, abuccal side, a lingual side, an interior surface, and an outer surface,the upper tray comprising: (a) a receptacle bounded by the interiorsurface of the upper tray; (b) a right side upper bite pad connected atan upper end to a lower surface of the right side of the upper tray,wherein the right side upper bite pad comprises a lower surface, ananterior surface, a posterior surface, a right side, and a left side,the right side upper bite pad extending anteriorly from a posteriorportion of the right side of the upper tray, wherein the lower surfaceof the right side upper bite pad is lower than a lower, coronal surfaceof the posterior portion of the right side upper tray; and (c) a leftside upper bite pad connected at an upper end to the lower surface ofthe left side of the upper tray, wherein the left side upper bite padcomprises a lower surface, an anterior surface, a posterior surface, aright side, and a left side, the left side upper bite pad extendinganteriorly from a posterior portion of the left side of the upper tray,wherein the lower surface of the left side upper bite pad is lower thanthe lower, coronal surface of a posterior portion of the left side uppertray; (d) a buccally facing anterior right side anchor on the outerbuccal surface of the anterior portion of the right side of the uppertray, and a buccally facing anterior left side anchor on the outerbuccal surface of the anterior portion of the left side of the uppertray; and (2) a lower tray having an anterior portion, a posteriorportion, a right side, a left side, a buccal side, a lingual side, aninterior surface, and an outer surface, the lower tray comprising: (a) areceptacle bounded by the interior surface of the lower tray; (b) aright side lower bite pad connected at a lower end to an upper surfaceof the right side of the lower tray, wherein the right side lower bitepad comprises an upper surface, an anterior surface, a posteriorsurface, a right side, and a left side, the right side lower bite padextending posteriorly from an anterior portion of the right side of thelower tray, wherein the upper surface of the right side lower bite padis higher than an upper, coronal surface of an anterior portion of theright side lower tray; (c) a first right side insert comprising a lowersurface, an upper surface, an anterior surface, a posterior surface, aright side, and a left side, wherein the lower surface faces and/orcontacts the upper surface of the right side of the lower trayposteriorly with respect to the right side lower bite pad, wherein theposterior surface of the right side lower bite pad comprises a recessand the anterior surface of the first right side insert comprises aprojection adapted to fit within the recess and thereby secure the firstright side insert to the right side lower bite pad; (d) a left sidelower bite pad connected at a lower end to an upper surface of the leftside of the lower tray, wherein the left side lower bite pad comprisesan upper surface, an anterior surface, a posterior surface, a rightside, and a left side, the left side lower bite pad extendingposteriorly from an anterior portion of the left side of the lower tray,wherein the upper surface of the left side lower bite pad is higher thanan upper, coronal surface of the anterior portion of the left side lowertray; (e) a first left side insert comprising a lower surface, an uppersurface, an anterior surface, a posterior surface, a right side, and aleft side, wherein the lower surface faces and/or contacts the uppersurface of the left side of the lower tray posteriorly with respect tothe left side lower bite pad, wherein the posterior surface of the leftside lower bite pad comprises a recess and the anterior surface of thefirst left side insert comprises a projection adapted to fit within therecess and thereby secure the first left side insert to the left sidelower bite pad; (f) a buccally facing anterior right side anchor on theouter buccal surface of the anterior portion of the right side of thelower tray, and a buccally facing anterior left side anchor on the outerbuccal surface of the anterior portion of the left side of the lowertray; and (g) a buccally facing posterior right side anchor on the outerbuccal surface of the posterior portion of the right side of the lowertray, and a buccally facing posterior left side anchor on the outerbuccal surface of the posterior portion of the left side of the lowertray, wherein the posterior surface of the right side insert comprisesan engagement surface which contacts the anterior surface of the rightside lower bite pad, and wherein the posterior surface of the left sideinsert comprises an engagement surface which contacts the anteriorsurface of the left side lower bite pad, thereby limiting a forwardpositioning of the upper tray with respect to the lower tray, therebyalleviating snoring and/or apnea when the oral appliance is used by asubject, and wherein the receptacles of the upper tray and the lowertray are each configured to receive and retain an orthodontic tray, orwherein the receptacles of the upper tray and the lower tray are eachconfigured to reposition one or more teeth of a subject and/or to changethe configuration of a subject's mandible and/or maxilla when theappliance is worn by the subject.
 2. The oral appliance of claim 1,further comprising an elastic band connecting the anterior left sideanchors of the upper tray and the lower tray, an elastic band connectingthe anterior right side anchors of the upper tray and the lower tray, anelastic band connecting the anterior left side anchor of the upper traywith the posterior left side anchor of the lower tray, and an elasticband connecting the anterior right side anchor of the upper tray withthe posterior right side anchor of the lower tray.
 3. The oral applianceof claim 1, wherein the anchors are selected from the group consistingof a button, a hook, and a Herbst screw.
 4. The oral appliance of claim1, wherein each insert is connected to a respective bite pad with aninterference fit.
 5. The oral appliance of claim 1, further comprising afirst orthodontic tray and a second orthodontic tray, wherein theorthodontic trays can be received within the receptacles of the oralappliance.
 6. The oral appliance of claim 1, further comprisingorthodontic trays, wherein the orthodontic trays can be received withinthe receptacles of the oral appliance and, wherein the orthodontic trayscomprise a series of first orthodontic trays and a series of secondorthodontic trays, and wherein each of the orthodontic trays in theseries comprises a different configuration in order to change theposition of the subject's teeth and/or the shape of the subject's jaw.7. The oral appliance of claim 6, wherein receptacle of the upper trayis shaped to receive all of the first orthodontic trays, and receptacleof the lower tray is shaped to receive all of the second orthodontictrays.
 8. A method of treating snoring and/or sleep apnea comprising thestep of providing the oral appliance of claim 1 to a subject in needthereof.
 9. The oral appliance of claim 1, wherein the projections ofthe first right side insert and the first left side insert eachcomprises a wedge having sides that extend laterally and posteriorly andthe recesses of the right side lower bite pad and the left side lowerbite pad each is wedge-shaped and configured to receive and retain therespective projection.
 10. The oral appliance of claim 1, furthercomprising a second right side insert and a second left side insertprovided with the appliance, wherein the second right side insert andsecond left side insert each have a pair of lateral sides, and whereinthe length of the lateral sides of the second right side insert andsecond left side insert are different than the length of the first rightside insert and first left side insert.